MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR SCB

Model Number 26432020-1

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that there was event with a thermoflator scb.According to the information received: temporarily no overpressure alarm.Occurred.The failure was during procedure.Further information is not available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The customer's reported malfunction was: "temporarily no overpressure alarm ".It turned out that the gas pressure regulation of the thermoflator scb was temporarily not working, causing too much gas to flow into the patient's abdominal cavity.A defective component has been identified.A defective linear actuator causes too much gas to flow into the patient's abdominal cavity.This does not affect the correct function of the unit.Even if the linear actuator were to get stuck, the safety functions of the unit would take effect and an overpressure would be detected and relieved.The complaint notifications were checked for similar complaints.2 similar complaints were found in relation to a consumption of (b)(4) units.No indication for a systematic issue.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: THERMOFLATOR SCB
• Type of Device: THERMOFLATOR SCB
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17290684
• MDR Text Key: 318748477
• Report Number: 9610617-2023-00821
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other